On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces extensive sanctions packages against Russian media personalities on 20 January 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Polish press reports on the possible 10th package of EU sanctions against Russia on 16 January 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
On 10 November 2022, the National Coordination Centre for Ethics Committees published the updated versions of the ‘Contract for the performance of clinical trials on medicines’, the ‘Contract for the performance of independent clinical trials on medicines’ and the ‘Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use’.
On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU.
On 11 November 2022, the Ministry of Ecological Transition answered the Confindustria’s question on whether the packaging of medicines for human use, medical devices and in-vitro diagnostic medical devices must comply with the environmental labelling requirements set forth in Article 219, Section 5, of Legislative Decree 152/2006, starting from 1 January 2023.
On 9 December 2022, the Italian Government preliminary approved the draft legislative decree implementing Directive EU 2019/1937 (so called “Whistleblowing Directive”), aimed at protecting whistleblowers against retaliation and other negative consequences.
Several Regions and Autonomous Provinces published the measures requiring medical device companies to pay, within 30 days, payback amounts aimed at covering the overrun of the expenditure ceiling for the purchase of medical devices for the years 2015, 2016, 2017 and 2018.